SAGE-718 on FDA Fast Track as Potential Huntington’s Therapy

The U.S. Food and Drug Administration (FDA) has granted fast track designation to SAGE-718 as a potential therapy for Huntington’s disease.

The FDA gives this designation to experimental medications with the potential to improve medical care for serious health conditions and fill unmet needs. The designation gives the therapy’s developer — Sage Therapeutics — access to more frequent meetings with the FDA to review the development plan for the medicine, with the goal of getting effective medicines to market faster.

“The FDA Fast Track Designation is an important milestone in the development of SAGE-718, as it provides opportunities to engage collaboratively with the FDA to further clinical development and future regulatory review of SAGE-718 for the treatment of [Huntington’s disease],” Jim Doherty, PhD, chief research officer at Sage, said in a press release.

SAGE-718 is a first-in-class oral medication that works by modulating the activity of the N-methyl-D-aspartate (NMDA) receptor, a protein that’s present on the surface of neurons (nerve cells) and plays key roles in learning and memory. Abnormal activity of the NMDA receptor is thought to contribute to the death and dysfunction of neurons in people with Huntington’s and other neurological diseases.

The safety, tolerability, and pharmacologic properties of SAGE-718 in healthy subjects has been assessed in several clinical trials. Sage sponsored a Phase 1 trial (NCT03787758) that tested the experimental medication’s safety in six people with Huntington’s, which concluded in 2019.

The company is also running ongoing trials to test SAGE-718’s safety in people with Alzheimer’s disease (NCT04602624) and Parkinson’s disease (NCT04476017).

SAGE-718: oxysterol/cholesterol analogue; exact chemical structure undisclosed – NMDA receptor positive allosteric modulator.

September 22, 2021

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